Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial

Abstract

Importance: Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.

Objective: To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.

Design, setting, and participants: Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.

Interventions: The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.

Main outcomes and measures: Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.

Results: One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.

Conclusions and relevance: In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.

Trial registration: ClinicalTrials.gov Identifier: NCT03500536.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Mohr has an ownership interest in Adaptive Health Inc, which has a license from Northwestern University to commercialize IntelliCare. Drs Graham and Kwasny and Ms Kaiser have received consulting fees from Actualize Therapy LLC. Dr Graham reported grants from the National Institute of Diabetes and Digestive and Kidney Diseases during the conduct of the study and from the National Institute of Mental Health outside the submitted work. Dr Greene reported grants from Actualize Therapy during the conduct of the study. Dr Powell reported grants from the National Institutes of Health Small Business Innovation Research during the conduct of the study. Dr Mohr reported grants from the National Institute of Mental Health during the conduct of the study; personal fees from Apple Inc; and other support from Actualize Therapy Inc and Otsuka Pharmaceuticals outside the submitted work; in addition, Dr Mohr had a patent to US Patent 15/654,245, 2018 pending. No other disclosures were reported.

Figures

Figure 1.. CONSORT Flow Diagram

Figure 2.. Change in Least Square Means Scores

A, Change in depression least square mean scores by intervention condition over the intervention period (with imputed data). B, Change in anxiety least square mean scores by intervention condition over the intervention period (with imputed data).